O-arm” O2 Imaging System, Product Number/CFN: BI-700-02000
Medical device recall Z-0767-2020. Published in FDA’s Enforcement Report on Jan 8, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 8, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 27 states named in where it went
- 90 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to a manufacturing issue affecting particular O-arm” O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
O-arm” O2 Imaging System, Product Number/CFN: BI-700-02000
90, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SN: C2155 C2180 C2193 C2203 C2213 C2223 C2233 C2243 C2257 C2267 C2157 C2181 C2194 C2204 C2214 C2224 C2234 C2247 C2258 C2268 C2165 C2182 C2195 C2205 C2215 C2225 C2235 C2248 C2259 C2166 C2183 C2196 C2206 C2216 C2226 C2236 C2250 C2260 C2167…
Every code shown here, 799 characters
SN: C2155 C2180 C2193 C2203 C2213 C2223 C2233 C2243 C2257 C2267 C2157 C2181 C2194 C2204 C2214 C2224 C2234 C2247 C2258 C2268 C2165 C2182 C2195 C2205 C2215 C2225 C2235 C2248 C2259 C2166 C2183 C2196 C2206 C2216 C2226 C2236 C2250 C2260 C2167 C2185 C2197 C2207 C2217 C2227 C2237 C2251 C2261 C2169 C2186 C2198 C2208 C2218 C2228 C2238 C2252 C2262 C2172 C2187 C2199 C2209 C2219 C2229 C2239 C2253 C2263 C2176 C2189 C2200 C2210 C2220 C2230 C2240 C2254 C2264 C2177 C2190 C2201 C2211 C2221 C2231 C2241 C2255 C2265 C2178 C2192 C2202 C2212 C2222 C2232 C2242 C2256 C2266 UDIs: 00763000074104, 00763000132378, 00763000074128, 00763000134488 00763000081003, 00763000074067, 00763000168605, 00763000074135, 00763000134518, 00763000081041, 00763000135829, 00763000081102, 00763000074050, 00763000074098, 00763000135836
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US: AR CA CO CT FL ID IL IN KS KY MI MN MO NC ND NE NY OH OR PA SC SD TX VA WA WI WV OUS: AUSTRALIA CANADA CHINA FRANCE GERMANY INDIA ITALY JAPAN LEBANON NETHERLANDS ROMANIA SAUDI ARABIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM
The states and territories these words name
27 states and territories.
Every one of them
- Arkansas
- California
- Colorado
- Connecticut
- Florida
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Michigan
- Minnesota
- Missouri
- North Carolina
- North Dakota
- Nebraska
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 15, 2019.
- FDA classified it on Dec 31, 2019.
- FDA’s Enforcement Report published it on Jan 8, 2020.
- FDA terminated it on Sep 19, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Navigation, Inc.-Littleton, of Littleton, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.